The Life Cycle of a Software Validation Protocol

Description:

In many regulated environments both product software and software that could impact product quality are expected to be validated. The scope of this course is intended to focus on the development and execution of test protocols. While this approach and these techniques apply to regulated environments, they are intended to be practical enough for any environment.

Curriculum For This Course:

Introduction

Overview

1 min 23 secs

Learning objectives

2 mins 12 secs

Who should take this course?

58 ses

Module overview

1 min 52 secs

Module 1: Introduction to Software Validation

Overview

1 min 21 secs

Best practices

2 min 10 secs

Introduction to software validation

1 min 41 secs

Scope

45 secs

Types of software

1 min 32 secs

Module 2: Documentation Infrastructure

Overview

1 min 30 secs

The validation master plan (VMP)

2 min 10 secs

Ensure a solid foundation

1 min 50 secs

Ambiguous words

2 min 10 secs

Run-on requirements

1 min 39 secs

Requirement traps

2 mins 01 sec

Requirements

1 min 39 secs

Product software requirements

2 min 20 secs

Organize requirements

1 min 18 secs

Review activity

5 mins

Module 3: Protocol Development

Overview

1 min 20 secs

Protocol development

2 mins 10 secs

Define test objectives

1 min 34 secs

Test development considerations

2 mins 02 secs

Considering precision

1 min 23 secs

Trace requirements to test objectives

2 mins 21 secs

Organize the protocols

1 min 30 secs

Formal protocols

3 mins 01 sec

Module 4: Testing

Overview

1 min 20 secs

Installation qualification

2 mins 20 secs

Operational qualification

2 mins 10secs

Performance qualification

2 mins 58 secs

Static analysis

1 min 34 secs

Unit-level testing

1 min 23 secs

Dynamic analysis

2 mins 31 secs

Ad-hoc or exploratory testing

1 min 32 secs

Misuse testing

58 secs

Conceptualize the test

1 min 49 secs

Set up the test

2 mins 14 secs

Equipment and software used for testing

1 min 30 secs

Write the test steps

2 mins 10 secs

Use of screenshots

1 min 36 secs

A few more details

2 mins 14 secs

How much is enough?

1 min 39 secs

Module 5: Preparing for and Executing Protocols

Overview

1 min 23 secs

Protocol execution preparation

2 mins 51 secs

Identifying test personnel

1 min 39 secs

Gathering test equipment

2 mins 10 secs

Executing the protocols in a controlled environment

1 min 21 secs

Recording test results

2 mins 01 secs

Deviant behavior

1 min 47 secs

Variances

2 min 10 secs

Procedural errors in the expected results

1 min 08 secs

Handling attachments

2 mins 36 secs

Conclusion

2 mins 58 secs

Final Assessment

Certification

shares

Author

Don Hurd

Don Hurd has over 30 years of experience in supporting development of real-time, embedded applications in regulated environments. He is an ASQ Certified Quality Auditor with diverse background providing a unique insight into achieving product quality and ensuring high productivity of development organizations.

Description:

In many regulated environments both product software and software that could impact product quality are expected to be validated. The scope of this course is intended to focus on the development and execution of test protocols. While this approach and these techniques apply to regulated environments, they are intended to be practical enough for any environment.

Curriculum For This Course:

Introduction

Overview

1 min 23 secs

Learning objectives

2 mins 12 secs

Who should take this course?

58 ses

Module overview

1 min 52 secs

Module 1: Introduction to Software Validation

Overview

1 min 21 secs

Best practices

2 min 10 secs

Introduction to software validation

1 min 41 secs

Scope

45 secs

Types of software

1 min 32 secs

Module 2: Documentation Infrastructure

Overview

1 min 30 secs

The validation master plan (VMP)

2 min 10 secs

Ensure a solid foundation

1 min 50 secs

Ambiguous words

2 min 10 secs

Run-on requirements

1 min 39 secs

Requirement traps

2 mins 01 sec

Requirements

1 min 39 secs

Product software requirements

2 min 20 secs

Organize requirements

1 min 18 secs

Review activity

5 mins

Module 3: Protocol Development

Overview

1 min 20 secs

Protocol development

2 mins 10 secs

Define test objectives

1 min 34 secs

Test development considerations

2 mins 02 secs

Considering precision

1 min 23 secs

Trace requirements to test objectives

2 mins 21 secs

Organize the protocols

1 min 30 secs

Formal protocols

3 mins 01 sec

Module 4: Testing

Overview

1 min 20 secs

Installation qualification

2 mins 20 secs

Operational qualification

2 mins 10secs

Performance qualification

2 mins 58 secs

Static analysis

1 min 34 secs

Unit-level testing

1 min 23 secs

Dynamic analysis

2 mins 31 secs

Ad-hoc or exploratory testing

1 min 32 secs

Misuse testing

58 secs

Conceptualize the test

1 min 49 secs

Set up the test

2 mins 14 secs

Equipment and software used for testing

1 min 30 secs

Write the test steps

2 mins 10 secs

Use of screenshots

1 min 36 secs

A few more details

2 mins 14 secs

How much is enough?

1 min 39 secs

Module 5: Preparing for and Executing Protocols

Overview

1 min 23 secs

Protocol execution preparation

2 mins 51 secs

Identifying test personnel

1 min 39 secs

Gathering test equipment

2 mins 10 secs

Executing the protocols in a controlled environment

1 min 21 secs

Recording test results

2 mins 01 secs

Deviant behavior

1 min 47 secs

Variances

2 min 10 secs

Procedural errors in the expected results

1 min 08 secs

Handling attachments

2 mins 36 secs

Conclusion

2 mins 58 secs

Final Assessment

Certification

shares

Author

Don Hurd

Don Hurd has over 30 years of experience in supporting development of real-time, embedded applications in regulated environments. He is an ASQ Certified Quality Auditor with diverse background providing a unique insight into achieving product quality and ensuring high productivity of development organizations.